Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients IMPACTE-01
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- QLQ-ELD14 Questionnaire
研究概览
简要总结
Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR).
Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors.
In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction.
In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL.
the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.
详细描述
A short description, 5000 characters
Intro:
Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR).
Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors.
In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 70 years
- •Pathology confirmation of invasive SCC or BCC
- •At least one of high-risk factors for recurrence (R0 but close margins, location/size, microscopic perineural invasion, recurrent primary disease, immunosuppression, thickness including Breslow and Clark level, poorly-moderately differentiated)
- •No indication of regional nodal RT
- •No prior RT to the treated site
- •Written consent from patient or his/her legal representative, trustworthy person or family member if the person is physically unable to give his or her written consent
- •Life expectancy ≥ 6 months, as clinically estimated by the investigator in charge of enrolment
- •No contraindication for surgery and RT after multidisciplinary board meeting evaluation
- •Affiliated to a social security scheme
排除标准
- •Macroscopic incomplete resection of the primary tumor (≥ R1)
- •Patient with severe dementia not allowing follow-up
- •Any psychological, familial, sociological, geographical or logistical reasons that would prevent participation to surveillance during treatment and follow-up
- •Other active cancers in treatment
- •Participation in another interventional study (therapeutic trial interfering with the study's endpoints)
- •Patient on AME (state medical aid)
- •Persons deprived of their liberty by a judicial or administrative decision
结局指标
主要结局
QLQ-ELD14 Questionnaire
时间窗: at 3 years
Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT
rate of Toxicity
时间窗: during RadiotherapyT
Acute and late toxicity, as assessed by CTCAE v4.03 criteria
Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
时间窗: at 3 years
Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT
efficacy of treatment modalities on regional recurrence (RR), at 3-year follow-up
时间窗: at 3 years
progression-free survival (PFS)
时间窗: at 3-year follow-up
overall survival (OS)
时间窗: at 3 years
次要结局
未报告次要终点